Early Versus Late Intubation Trial in Physician Manned Emergency Medical Services (ELITE)
This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.
Procedure: Early Intubation
Procedure: Late intubation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Trial Comparing Competent EARLY-intubation to LATE-intubation in Patients With Prehospital GCS < 9 and Short Transport Time to Hospital.|
- 30 days mortality after injury or illness. [ Time Frame: 30 days after illness or injury ] [ Designated as safety issue: Yes ]Dead or alive
- Neurologic outcome at 6 months after injury or illness. [ Time Frame: 6 months after illness or injury ] [ Designated as safety issue: Yes ]Neurologic outcome will be assessed using glascow outcome scores (GOS-E)
- Intubation success rates and airway management complications for the entire cohort and for key subsets [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
- Length of hospital stay, complications and degree of disability at discharge. [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
- Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax). [ Time Frame: up to 6 months after illness or injury ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Early Intubation
Early intubation is defined as prehospital intubation on the scene of the patient illness/injury, or where the EMS physician first meets the patient (e.g en route to hospital). Intubation includes drug assisted and/or rapid sequence intubation (RSI) with endotracheal tube.
|Procedure: Early Intubation|
Active Comparator: Late intubation
Late intubation is defined as on-scene prehospital high-flow (> 10 L/min) supplemental oxygen by mask, assisted bag-mask-ventilation by EMS physician if required and stable recovery position during transport to hospital. Intubation should be done on arrival in the emergency department.
|Procedure: Late intubation|
The ELITE trial is a prospective randomized controlled trial (RCT) to compare competent EARLY-intubation to LATE-intubation in patients with on-scene Glasgow Coma Scale (GCS) < 9 and short ambulance transport times (< 20 min) to hospital.
The study aims to establish if advanced airway management with endotracheal intubation (ETI) in the field by specially trained Emergency Medical Services (EMS) physicians - compared to endotracheal intubation (ETI) performed by physicians in the emergency department in the same group - improves outcome in terms of 30-day mortality, degree of disability at discharge, complications and length of hospital stay, and neurologic outcome at 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730001
|Haukeland University Hospital|
|Bergen, Norway, 5021|
|Norwegian Air Ambulance Foundation|
|Drøbak, Norway, 1441|
|Principal Investigator:||Geir A Sunde, MD||Norwegian Air Ambulance Foundation|
|Study Chair:||Stephen JM Sollid, MD, PhD, Ass.Prof||Norwegian Air Ambulance Foundation|
|Study Director:||Hans M Lossius, MD, PhD, Prof||Norwegian Air Ambulance Foundation|
|Principal Investigator:||Espen Fevang, MD||Norwegian Air Ambulance Foundation|